Drug Master Files for: ASENAPINE MALEATE
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ASENAPINE MALEATE Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 25745 | A | II | 3/26/2012 | DR REDDYS LABORATORIES LTD | ASENAPINE MALEATE |
| 26104 | A | II | 5/30/2012 | OLON SPA | ASENAPINE MALEATE |
| 26785 | A | II | 3/8/2013 | MSN ORGANICS PRIVATE LTD | ASENAPINE MALEATE [ROUTE CODE AN] |
| 26973 | A | II | 3/23/2013 | MSN ORGANICS PRIVATE LTD | ASENAPINE MALEATE [ROUTE CODE AOI] |
| 27086 | A | II | 5/17/2013 | MYLAN LABORATORIES LTD | ASENAPINE MALEATE |
| 27185 | A | II | 7/17/2013 | SUN PHARMACEUTICAL INDUSTRIES LTD | ASENAPINE MALEATE |
| 27194 | A | II | 7/4/2013 | ALEMBIC PHARMACEUTICALS LTD | ASENAPINE MALEATE |
| >DMF No. | >Status | >Type | >Submission Date | >Holder | >Subject |
Drug Master File Glossary
STATUS OF DMFS
- A = Active. This means that the DMF was found acceptable for filing, administratively, and is up-to-date.
- I = Inactive
- N = Not an assigned number
- P = DMF Pending Filing Review
TYPES OF DMFs
- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)
- Type II Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation, or Drug Product
- Type III Packaging Material
- Type IV Excipient, Colorant, Flavor, Essence, or Material Used in Their Preparation
- Type V FDA Accepted Reference Information
